CQV Engineer II

The Role:Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients.Moderna is strengthening its presence in Norwood, Massachusetts, a cornerstone of our manufacturing and operational excellence. Our Norwood campus translates mRNA science into scalable impact, supporting the global delivery of our medicines. We welcome talent ready to drive innovation and make a meaningful difference for patients worldwide.In this role, you will support commissioning, qualification, and validation (CQV) activities to ensure facilities, utilities, equipment, systems (FUSE), and analytical instruments remain in a qualified and compliant state within a cGMP manufacturing environment.You will execute validation lifecycle activities, author technical documentation, and collaborate cross-functionally to maintain regulatory compliance and operational readiness.This is a highly technical, site-based role embedded within our manufacturing ecosystem, ensuring infrastructure performance meets the highest quality and regulatory standards.Here’s What You’ll Do:Execute commissioning, qualification, and validation (CQV) activities for facilities, utilities, equipment, systems (FUSE), and analytical instruments.Author and execute validation lifecycle documentation including:User Requirements Specification (URS) supportRisk assessmentsIQ/OQ/PQ protocolsSummary reportsSupport deviation investigations, contribute to structured root cause analysis, and assist in CAPA development.Perform change control impact assessments and support implementation planning.Participate on cross-functional project teams supporting capital projects and site initiatives.Represent CQV during internal and external inspections.Ensure SOPs and validation documentation meet site procedures and regulatory requirements.Utilize validation tools and qualification equipment (including data loggers such as Ellab) to support qualification activities.Contribute to maintaining facilities and equipment in a continuous state of compliance and inspection readiness.Support modernization and digitization of validation systems where possible, leveraging data-driven tools and emerging digital capabilities to enhance efficiency and compliance.Here’s What You’ll Need (Basic Qualifications):B.S. in Engineering (Chemical or Mechanical preferred; other related scientific disciplines will be considered).2–5 years of CQV or validation experience in cGMP manufacturing environments.Working knowledge of validation lifecycle principles and regulatory expectations.Ability to author and review technical documentation in compliance with site procedures.Structured problem-solving skills with the ability to support root cause investigations.Strong communication skills with the ability to collaborate across Engineering, Facilities, Operations, Automation, and Quality Assurance.This position is site-based, requiring you to be at Moderna’s site full-time. This position is not eligible for remote work.At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in the US and be able to maintain that status without the need for future sponsorship.Here’s What You’ll Bring to the Table (Preferred Qualifications):Ability to work independently on routine to moderately complex validation activities.Receives guidance on complex or high-risk projects.Contributes to continuous improvement initiatives within the CQV program.The key Moderna Mindsets you’ll need to succeed in the role:“We act with urgency; Action today compounds the lives saved tomorrow.”“We digitize everywhere possible using the power of code to maximize our impact on patients.”Pay & BenefitsAt Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needsA holistic approach to well-being, with access to fitness, mindfulness, and mental health supportFamily planning benefits, including fertility, adoption, and surrogacy supportGenerous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdownSavings and investment opportunities to help you plan for the futureLocation-specific perks and extrasThe salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.About ModernaSince our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.Our Working ModelAs we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.Moderna is a smoke-free, alcohol-free, and drug-free work environment.Equal OpportunitiesModerna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.AccommodationsWe’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io .Export Control NoticeThis position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.#LI-NB1 #J-18808-Ljbffr